Study Evaluating rhIL-11 in Active Crohn's Disease
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
Men and women age 16 years and over.
Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease)
Use of the following medications within the specified time period prior to randomization:
Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid)